The present invention relates generally to the fields of electronic data storage and privacy, and more specifically to controlling access to sensitive electronic files such as a person's medical history.
Proper medical diagnosis and subsequent treatment of a patient requires that medical care providers know specific facts regarding the patient's medical history, and have access to lab results, in a timely manner. The medical history assists the medical provider in evaluating a current medical problem and alerts the medical care provider to allergies, side effects of medications, and other potential scenarios, the knowledge of which is critical in treating the patient. A traditional medical history includes a list of the patient's major illnesses, or diseases, such as heart disease or diabetes, results of recent lab tests, including EKG's, current and past medications, known allergies, date last seen by the medical care provider, dates of last prescriptions and reasons for prescribing, and whether the reasons for prescribing constituted temporary or continuing conditions. It is also important that the medical care provider be able to access the patient's medical contact information including name, address and telephone number of a patient's primary care and specialist physicians.
Traditionally, each time a patient sees a doctor, or other medical care provider, the patient must fill out at least one medical history form prior to receiving treatment. The forms may be an initial history form for recording complete medical history when the patient had not been previously been treated by the medical care provider, or an update form for recording changes to the patient's medical history since the patient's last visit. In both cases, the patient completes the medical history information form relying on the patient's memory. The medical history information may not be accurate depending on many things including, a patient's recollection, a patient's understanding of his own medical condition, a patient's understanding of prior treatments received, as well as other factors that may lead to false, ambiguous or omitted medical history information.
In 1996, Congress enacted the Health Insurance Portability and Accountability Act (HIPAA). HIPAA gives the patient rights over his own medical history information, and contains rules on who may look at and receive the patient's medical information. The Congress called on the United States Department of Health & Human Services (HHS) to issue patient privacy protections as part of the HIPAA. Key provisions of the patient privacy protections involve a patient's access to his own medical records, limits on the use of a patient's medical information, and prohibitions on marketing the patient's medical information. Current abilities for the patient to access the patient's own medical history, particularly up-to-date medical information, is limited. The patient's access to the patient's own medical history is important because the access may lead to the patient determining existence of an error in the patient's medical history, or presence of a correct entry in the patient's history of which the patient himself was unaware.
The purpose of the protections issued by HHS is to ensure confidentiality, integrity and availability of electronically maintained records, as well as to protect against reasonably anticipated threats or hazards to security and integrity of the medical information and protect against illegal uses or disclosures of the information. In order to comply with HIPAA, it is important to have a system capable of accessing up-to-date medical history information while maintaining the confidentiality and privacy required by HIPAA. This may be accomplished by an ability for the patient to control the access, and the level of access, to the patient's medical history information, (thus having an ability to deny access to, or set a limit on the amount of, the medical information provided to particular medical providers, or others that may have limited access modules) at the time that medical treatment is sought, or by pre-authorization particularly in the event of an catastrophe or emergency. The need for particular elements of the patient's medical information may differ depending on the type of the medical treatment sought by the patient. For example, a primary care physician and a major specialist may require access to the patient's full medical history, while a podiatrist, a specialist in cosmetic surgery, a dentist or a pharmacist may require access to only limited medical history. The limitations on the medical history may be based on the type of the medical history (e.g., the patient may not wish the dentist or the podiatrist to access information related to the date a Pap Smear was last performed) or by most recent time period time (e.g., the patient may wish a pharmacist's access limited to prescriptions issued within the last six (6) months and to known allergies and contraindications). This scenario is particularly useful when the patient purchases prescriptions from different pharmacies, or when the patient requires the medical treatment when away from home.
In an emergency or other situation where a patient may not be able to give consent to access medical history at the time the medical treatment is needed due to lack of consciousness, incompetence and other reasons, it may be crucial for the medical care provider to be aware of the patient's medical history. Options for a medical care provider to access a medical history include, communicating with a contact, such as a family member of the patient, who has the access and can inform the medical care provider of the medical history of the patient, and determining that the patient had pre-authorized the access to his medical history, for such a situation. Determination of such pre-authorization could be made through the use of an item carried by the patient, such as a card with a magnetic strip or bar code and a Personal Identification Number (PIN) of the patient that can be matched on a centralized database.
In addition to the patient's condition changing with time, new information is disclosed regarding medications on a continuing basis. The new information may include additional side effects and reactions with other drugs that may be a contraindication in the use or continued use of a particular drug currently prescribed for the patient. Alternatively, a side effect or reaction may be corrected or removed for a particular drug, thus changing a drug that was previously contraindicated into a drug potentially beneficial to the patient. Thus, an important mechanism in providing for ongoing quality medical care is a system that tracks both the patient's history and the new information related to drugs, combined with a matching capability and automatic triggering of notices and warnings to the physician, the pharmacist and the patient. Additionally, whenever new information is detected about a drug, it may be important that an advisory mailer or e-mail to the patient be generated that provides the notice that new information has been released regarding a medication that the patient is taking, and suggests that the patient contact his physician to obtain this important information.
Mental illness or other medical conditions may render a person unsuitable to obtain certain government licenses and/or permits such as a permit to purchase a firearm or other potentially dangerous weapon. Each year, thousands of guns are sold to individuals who have experienced mental illness or other medical condition in one form or another. It may be important for the proper authorities to have the ability to access a warning flag related to an applicant's medical history indicating potential unsuitability. If the patient has been recently treated or is undergoing care, it may be crucial that the authorities be made aware that further investigation may be warranted. However, so as to avoid violating the applicant's privacy or confidentiality, no information may be given regarding the condition or history. The flag thus may provide notice to the authorities that further investigation into the suitability of the license or the permit applicant may be warranted. While the license or the permit may ultimately be issued, this gives the authorities the time and tools to properly investigate a potentially dangerous situation, and still preserve the privacy and the confidentiality rights under HIPAA.
Local, regional or nationwide catastrophes such has hurricanes, floods etc. may warrant the need for a data base of those affected. Federal agencies, e.g. FEMA, American Red Cross to mention a couple, work together but have no current common data base of information of those affected. The ability to generate a data base of those who are affected by such catastrophe, provide medicine in a timely manner, and notify emergency contact persons is needed.
The authority to access the patient's medical history may also be given to another person or entity that does not provide medical services or dispense drugs. This scenario is useful if the medical care provider does not have access to a system described herein, but knows the patient's contact. Also, the patient may specify that certain persons may access the medical history only with the permission of another person. Additionally, the medical history may be available in foreign languages to facilitate access in non-English speaking communities. There are many different scenarios where the authority to access the medical history, with or without the consent of another person, may be important. For example, the authority to access the patient's medical information may be given to the person identified as the patient's contact (e.g., spouse, friend, family member) so that the medical care provider of the patient may communicate with the patient's contact for the patient's medical history. Another example is one in which the authority to access and allow others to access the medical history of the child may best be placed with the child's parent, or legal guardian. In the case of divorced parents, the authority may be placed with both parents, a custodial parent, a dependent parent, a step-parent, a biological parent, a legal guardian or some combination thereof. This may be important when the patient is near his home or traveling away from home, perhaps in a different country, and when the patient is a child or an incompetent person.
Many physicians have converted or are converting to housing the medical history information in persistent electronic storage (Paperless Patient Charts) using their own systems. However, many of the physicians do not have the capability of converting their paper systems to their own electronic storage systems. It is important that the capability be made available to physicians to convert their paper files to the persistent electronic storage without the necessity of the physician implementing his own system. It may also be important if the use of said capability had the affect of providing simultaneously updating of the patient's information for more timely access by the other medical care providers, as well as eliminating duplicate data entry.
In current medical history databases, the patient's medical information is provided by the patient himself. It may be important both for the completeness and accuracy of the patient's medical history to have the up-to-date medical history provided directly by the physician or, alternatively, by a service made available to physicians for entering the medical history information.
Currently, the patient's medical information may be housed in persistent storage on a chip, known as a Smart Card. However, the Smart Card is difficult to maintain and be accurate. Additionally, a Smart Card Reader must be available to access the medical information from the Smart Card. Also, currently there are Internet based medical records, however such do not comply with HIPPA and in some systems data is entered by the patient not the physician. Allowing the patient to edit their own medical records, without the knowledge or consent of their attending physician places both the physician and patient at risk.
In order to provide similar benefits to military personnel, it is important that a system is adopted strictly for military uses whereby only Emergency Rooms would have access to a military file in the event of an emergency.